Esophageal Bougies
FDA 510(k) K830991 · Medovations, Inc.
510(k) numberK830991
Submission
- Device name
- Esophageal Bougies
- Applicant
- Medovations, Inc.
Mchenry, IL, US - Received
- March 29, 1983
- Decision date
- June 2, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNQ – Dilator, Esophageal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5365
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122924 | Cre Fixed Wire Ballon Dilation CatheterKNQ · Special | Boston Scientific Corp | 10/24/2012SE |
| K093236 | Ethicon Endo-Surgeryoptical DilatorKNQ · Special | Ethicon Endo-Surgery, Inc. | 11/10/2009SE |
| K090183 | Hercules 3 Stage Wire Guided Dilation BalloonKNQ · Special | Cook Endoscopy | 09/25/2009SE |
| K082995 | Smart DilatorKNQ · Traditional | Safestitch Medical | 02/06/2009SE |
| K061937 | Cook Endoscopy Esophageal Dilation BalloonKNQ · Traditional | Cook Endoscopy | 12/01/2006SE |
| K061787 | Maxforce TTS Single-Use Balloon DilatorKNQ · Traditional | Boston Scientific Corp | 09/21/2006SE |
| K060302 | Inscope Precision Balloon Dilator - Wire GuidedKNQ · Traditional | Cordis Europa, N.V. | 04/11/2006SE |
| K043605 | Inscope 3-STAGE Balloon DilatorKNQ · Traditional | Cordis Europa, N.V. | 02/04/2005SE |
| K033936 | Bard Eliminator PET Balloon DilatorsKNQ · Special | C.R. Bard, Inc. | 01/14/2004SE |
| K031147 | Optical DVS (Dual Vector Shearing) Esophageal DilatorKNQ · Traditional | Ethicon Endo-Surgery, Inc. | 01/12/2004SE |
More from Ethicon Endo-Surgery, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K142068 | Bulldog Biopsy Valve, Olympus and Fujinon;Pentax Compatible;Disposable Rrigating…OCX · Traditional | 03/10/2015SE |
| K002363 | Medovations Esophageal DilatorKNQ · Traditional | 11/01/2000SE |
| K972119 | Maloney Bouge (1210-XX)/HURST Bougie (1212-XX)FAT · Traditional | 02/02/1998SE |
| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K874309 | Urethal CatheterKNX · Traditional | 12/07/1987SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
Questions and answers
When was Esophageal Bougies cleared by the FDA?
Esophageal Bougies (K830991) received a 510(k) decision of Substantially Equivalent on June 2, 1983, 65 days after the submission was received.
What is the product code of K830991?
The FDA product code is KNQ – Dilator, Esophageal, a Class II (moderate risk) device regulated under 21 CFR 876.5365.